Active Ingredient(S)
Alcohol 80% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 74473-486
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Otis Products, Inc. for the product Hand Sanitizer (NDC 74473-486). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), use, warnings, do not use, otc - when using, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Use as hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soup and water are not available.
Use as hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
Warning for external use only. Flammable. Keep away from heat or flame.
Do Not Use
- in children less than 2 months of age
- on open wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
Purpose
Antiseptic
Package Label - Principal Display Panel
30 mL NDC: 74473-486-01
1oz. Hsan (Pk L Hsan80p1 Reference Rev200515)
118.3 mL NDC: 74473-486-04
4oz. Hsan (Pk L Hsan80p4 Reference Rev200515)
236.58 mL NDC: 74473-486-08
8oz. Hsan (Pk L Hsan80p8 Reference Rev200515)
946.35 mL NDC: 74473-486-32
32oz. Hsan (Pk L Hsan80p32 Reference Rev200515)
3785.4 mL NDC: 74473-486-28
1 Gal. Hsan (Pk L Hsan80p128 Reference Rev200515)
1892.7 mL NDC: 74473-486-64
1/2 Gal. Hsan (Pk L Hsan80p64 Reference Rev200515)
208197.64 mL NDC: 74473-486-55
55 Gal. Drum Hsan (Pk L Hsan80p55 Reference Rev200515)
* Please review the disclaimer below.
